Safety evaluation of an IPP tripeptide-containing milk protein hydrolysate.
Tensguard is a milk protein hydrolysate containing the lactotripeptide IPP. It is derived from cow's milk, which is present in the human diet and has a safe history of consumption. The final Tensguard product, a supplement or a functional food ingredient, is intended for use by people who want to follow a healthy diet and lifestyle in order to manage their blood pressure. The safety-in-use of commercial lactotripeptide-containing products has been confirmed in several in vitro and in vivo toxicity studies and in studies with humans. To support the safety, Tensguard was examined in three in vitro genotoxicity tests (bacterial reverse mutation test, mammalian cell gene mutation test and mammalian chromosomal aberration test) and in a 90-day repeated-dose oral toxicity study in rats. The genotoxicity tests confirm that Tensguard is not mutagenic or clastogenic. The NOAEL from the 90-day study was at the highest dose tested, i.e. 4% in the diet. The NOAEL is equivalent to an overall mean intake of 2 g Tensguard/kg body weight/day and corresponds to 40 mg IPP/kg body weight/day. This is 141-fold higher than the maximal anticipated intake. In conclusion, Tensguard is safe under the conditions of intended use.
Ponstein-Simarro Doorten
A Y
AY
DSM Food Specialties, Dept. Regulatory Affairs, A. Fleminglaan 1, p.p. 530-0375, 2613 AX Delft, The Netherlands. yolanda.ponstein@dsm.com
vd Wiel
J A G
JA
Jonker
D
D
D000818:Animals; D002417:Cattle; D002460:Cell Line; D002869:Chromosome Aberrations; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D005260:Female; D008297:Male; D051379:Mice; D008894:Milk Proteins; D009152:Mutagenicity Tests; D009842:Oligopeptides / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D013047:Specific Pathogen-Free Organisms
D008894:Milk Proteins; D009842:Oligopeptides; C489032:isoleucyl-prolyl-proline